Parexel Blog
Parexel Blog
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Learn MoreRare Disease and Orphan Drug Designations - What You Need to Know
Collectively, rare diseases affect over 30 million Americans. The Orphan Drug Act (ODA), which provides the statutory basis for FDA to designate a drug or biologic agent as a therapy for a...
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Learn MoreCritical Differences Between a Form FDA 483 and Warning Letters
There are many publications and services that analyze the observations contained in Form FDA 483 documents issued to manufacturers at the close of an inspection by the U.S. Food and Drug...
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Learn MoreDoes FDA Consistently Assess Product Quality Risk and Control in Applications?
Early in 2018, the Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) published a “white paper” which contained recommendations that drug companies could consider...
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Learn MoreReimagining The Global Value Dossier - Part 6
A clear value strategy is key to the success of any product attempting to enter the healthcare market; defining the right strategy should lead to the perfect positioning for your product and...
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Learn MoreWill FDA Withdraw an Approved Application Over Product Quality Problems?
There have been some recent headlines where the acting FDA Commissioner and other senior agency officials have stated that the FDA will consider the use of its full authorities to take...
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Learn MoreDon’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t
In a recent blog post, I wrote about how manufacturers can overcome data integrity problems that potentially imperil an application’s approval and commercializing a product. Sometimes...
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Learn MoreNew PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management
On November 28, 2019 the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a draft Recommendation for Participating Authorities, providing practical guidance for GMP...
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Learn MoreCommercial and Regulatory Strategy Considerations for Biotech
Many critical and innovative new therapies today, including those for rare and untreated diseases, are in the biotech pipeline. In fact, today biotech represents more than 80 percent of the...
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Learn MoreHow to align your market access activities with your product value strategy
The value strategy (also termed value story) for your product should act as the cornerstone for all market access activities. The value strategy drives your market access planning, which...
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Learn MoreA Long and Winding Road for Transdermal Products – FDA Has It Covered
On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...
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Learn MoreDemystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring
What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...
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Learn MoreFacilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications
FDA released its Guidance for Industry (GFI) regarding Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers on October 22, 2019. ...
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Learn MoreBiosimilars in China
In February 2019, National Drug Regulators in China approved the country’s first ever biosimilar product referencing Rituxan, a monoclonal antibody[1]. This biosimilar product, HLX01...
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Learn MoreRescuing Product Approvals from Data Integrity Issues
The pharmaceutical industry is inundated with a plethora of communications about data integrity. Most of those are focused on the downside – operational snags, negative inspection findings,...
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Learn MoreReimagining the Global Value Dossier - Part 4
Health Technology Assessment (HTA) agencies are increasingly demanding the inclusion of patient-relevant data in submission dossiers. It is evident that there is an effort to ensure...
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Learn MoreCommercializing Gene and Cellular Therapy
Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities. Designing a facility or finding a contract manufacturer to meet the...
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Learn MoreImpact of MDR, Article 117 medicinal products with an integral medical device
The medical devices regulation (MDR) and in-vitro diagnostics regulation (IVDR) replace the three current Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The Regulations...
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Learn MoreCritical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine
If you work in the pharmaceutical industry or follow the industry news, you’ve likely heard the phrases “Park doctrine” or “responsible corporate officer (RCO) doctrine” mentioned when the...
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Learn MoreCapturing the patient voice in market access communications
Patients have unique perspectives on their conditions that, when incorporated into value communications, can provide an authenticity and salience which would otherwise be lacking. Who knows...
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Learn MorePodcast: Driving Drug Development Innovation Through Patient Centricity
This PharmaVoice podcast explores patient-centric trials as a key innovation in drug development.
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